Patient data mining for clinical trials

ABSTRACT

The present invention provides a system and method for selecting prospective patients for a clinical trial. In various embodiments, a clinical trials brokerage is configured to receive requests from drug companies for lists of persons meeting specified criteria for clinical trials. Patient records are retrieved from a structured computerized patient record (CPR) data warehouse populated with comprehensive patient information mined from unstructured hospital records. A list of persons for whom consent was obtained can be outputted and forwarded to the entity interested in performing the clinical trial and which requested the list. Anonymity of a patient can be maintained until the patient provides consent to participate in the clinical trial.

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. ProvisionalApplication Serial No. 60/335,542, filed on Nov. 2, 2001, which isincorporated by reference herein in its entirety.

FIELD OF THE INVENTION

[0002] The present invention relates to medical information processingsystems, and, more particularly to a computerized system and method forselecting persons for clinical trials.

BACKGROUND OF THE INVENTION

[0003] Selection of persons for clinical trials is an expensive process.It is estimated that it costs drug companies several thousand dollarsfor each participant selected. Furthermore, sometimes even after beingselected, persons must be dropped from a trial because of inaccurate orincorrect information. This may delay the trial, causing an even greaterexpense.

[0004] Although drug companies try to get the word out by placingadvertisements or through direct contact with physicians, the selectionprocess is generally quite inefficient. Physicians tend to be busy anddo not always have time to respond to requests for patients, andpatients may not see the advertisements for clinical trials or subscribeto the periodicals where they are placed.

[0005] Moreover, physicians at a specialized medical center tend torefer patients to trials sponsored at that center. Many physicians areunaware of all the available clinical trials because of the time ittakes to keep current on all available trials for every patient that thephysician sees.

[0006] In addition, clinical trials often call for very specificselection criteria and it may be difficult to ascertain if a particularperson qualifies for a trial. Furthermore, because hospitals typicallystore information in an unstructured manner, it may be impossible usinghospital records to select patients qualifying for particular clinicaltrials.

[0007] An equally important problem is that of matching clinical trialsto specific patients. For example, for cancer alone, at any point intime there are over 600 trials in progress. Statistics show thatclinical trial web sites total 75,000 hits every week, mostly frompatients seeking information about trials, who are trying to fet addedto a trial. Estimates from National Cancer Institute indicate that onlytwo percent of those patients eligible for a trial are in a trial. Thus,it is critically important for an individual to know if he or she may beeligible for a trial.

[0008] Given the importance and expense of selecting qualified personsfor clinical trials, it would be desirable and highly advantageous toprovide improved techniques for automatically selecting prospectiveparticipants for clinical trials.

SUMMARY OF THE INVENTION

[0009] The present invention provides a technique for selectingprospective participants in a clinical trial.

[0010] In various embodiments of the present invention, a method isprovided that includes receiving a request for a list of prospectiveparticipants meeting specified criteria for a clinical trial. A set ofpatient records is then retrieved to determine persons meeting thespecified criteria.

[0011] The specified criteria may include probability information, thusallowing the selection of patients likely to meet the specified criteriafor the clinical study (e.g., 90% likelihood of diabetes, 70% likelihoodof hypertension). In this case, the relevant patient records wouldinclude probabilistic information to allow for such selection.Additional information for each prospective participant may also beretrieved. This additional information may include information aboutother clinical trials that the person participated in, including whethera placebo was administered.

[0012] Furthermore, persons may still be selected even though not allinformation needed to determine whether a person qualifies in allrespects for a clinical trial is present.

[0013] Consent to participate in a clinical trial should be obtained. Alist of persons for whom consent was obtained can be outputted andforwarded to an entity interested in performing the clinical trial.Typically, this is a drug company. Physicians may be notified of theirInstitutional Review Board (IRB) statuses (e.g., ‘approved’, ‘pending’,or ‘not approved’. Expiration dates of their status may be forwarded toapproved physicians.

[0014] Because patient confidentiality is important, the anonymity of aperson meeting the specified criteria must be preserved. The process ofobtaining consent may include selecting physicians associated with thepersons meeting the specified criteria, requesting approval toparticipate from each of the selected physicians, and providing consentinformation to persons meeting the specified criteria whose physicianprovided approval to participate in the clinical trial.

[0015] To further facilitate the process, questionnaires may beprovided. These questionnaires may be used to ascertain qualificationsfor the clinical trial.

[0016] Additionally, compensation and fees can be determined for theparties involved. For example, participating physicians may becompensated. The entity requesting the list may be charged a fee. Thepatients participating in the clinical trial may also be compensated.

[0017] The data source used to determine the persons eligible for theclinical trial may include a data warehouse. Further, it may bepopulated with structured information obtained from mining unstructuredpatient records. The patient records may include patient informationobtained from a plurality of participating health care providers, suchas hospitals.

[0018] In various alternative embodiments of the present invention, asystem for selecting prospective clinical trials for an individualpatient is provided. The system includes a clinical trials database, adata source containing patient information, and a clinical trialsbrokerage for generating a list of clinical trials for patients meetingspecified criteria associated with the clinical trials. At least some ofthe information in the data source containing patient information may beobtained from mining unstructured patient records.

[0019] These and other aspects, features and advantages of the presentinvention will become apparent from the following detailed descriptionof preferred embodiments, which is to be read in connection with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020]FIG. 1 is a block diagram of a computer processing system to whichthe present invention may be applied according to an embodiment of thepresent invention;

[0021]FIG. 2 shows an exemplary clinical trials brokerage systemaccording to an embodiment of the present invention;

[0022]FIG. 3 shows an exemplary clinical trials brokerage systemaccording to another embodiment of the present invention; and

[0023]FIG. 4 shows a flow diagram outlining an exemplary technique forselecting a person for a clinical trial according to an embodiment ofthe present invention.

DESCRIPTION OF PREFERRED EMBODIMENTS

[0024] To facilitate a clear understanding of the present invention,illustrative examples are provided herein which describe certain aspectsof the invention. However, it is to be appreciated that theseillustrations are not meant to limit the scope of the invention, and areprovided herein to illustrate certain concepts associated with theinvention.

[0025] It is also to be understood that the present invention may beimplemented in various forms of hardware, software, firmware, specialpurpose processors, or a combination thereof. Preferably, the presentinvention is implemented in software as a program tangibly embodied on aprogram storage device. The program may be uploaded to, and executed by,a machine comprising any suitable architecture. Preferably, the machineis implemented on a computer platform having hardware such as one ormore central processing units (CPU), a random access memory (RAM), andinput/output (I/O) interface(s). The computer platform also includes anoperating system and microinstruction code. The various processes andfunctions described herein may either be part of the microinstructioncode or part of the program (or combination thereof) which is executedvia the operating system. In addition, various other peripheral devicesmay be connected to the computer platform such as an additional datastorage device and a printing device.

[0026] It is to be understood that, because some of the constituentsystem components and method steps depicted in the accompanying figuresare preferably implemented in software, the actual connections betweenthe system components (or the process steps) may differ depending uponthe manner in which the present invention is programmed.

[0027]FIG. 1 is a block diagram of a computer processing system 100 towhich the present invention may be applied according to an embodiment ofthe present invention. The system 100 includes at least one processor(hereinafter processor) 102 operatively coupled to other components viaa system bus 104. A read-only memory (ROM) 106, a random access memory(RAM) 108, an I/O interface 110, a network interface 112, and externalstorage 114 are operatively coupled to the system bus 104. Variousperipheral devices such as, for example, a display device, a diskstorage device(e.g., a magnetic or optical disk storage device), akeyboard, and a mouse, may be operatively coupled to the system bus 104by the I/O interface 110 or the network interface 112.

[0028] The computer system 100 may be a standalone system or be linkedto a network via the network interface 112. The network interface 112may be a hard-wired interface. However, in various exemplaryembodiments, the network interface 112 can include any device suitableto transmit information to and from another device, such as a universalasynchronous receiver/transmitter (UART), a parallel digital interface,a software interface or any combination of known or later developedsoftware and hardware. The network interface may be linked to varioustypes of networks, including a local area network (LAN), a wide areanetwork (WAN), an intranet, a virtual private network (VPN), and theInternet.

[0029] The external storage 114 may be implemented using a databasemanagement system (DBMS) managed by the processor 102 and residing on amemory such as a hard disk. However, it should be appreciated that theexternal storage 114 may be implemented on one or more additionalcomputer systems. For example, the external storage 114 may include adata warehouse system residing on a separate computer system.

[0030] Those skilled in the art will appreciate that other alternativecomputing environments may be used without departing from the spirit andscope of the present invention.

[0031] Referring to FIG. 2, a clinical trials brokerage 250 isillustrated. The clinical trials brokerage 250 is shown operativelyconnected to a data repository which contains patient informationtypically collected from one or more health care organization, such ashospitals. This data repository is called a structured clinical patientrecord (CPR) 280. In various embodiments of the present invention, aplurality of drug companies, such as drug company 210, request lists ofpersons meeting specified criteria for clinical trials. The structuredCPR 280 is then consulted to obtain the lists of persons meeting thespecified criteria.

[0032] The specified criteria may include probability information, thusallowing the selection of patients likely to meet the specified criteriafor the clinical study (e.g., 90% likelihood of diabetes, 70% likelihoodof hypertension). In this case, the relevant patient records wouldinclude probabilistic information.

[0033] Furthermore, persons may still be selected even though not allinformation needed to determine whether a patient qualifies in allrespects for a clinical trial is present. In this case, the list wouldinclude “persons of interest” some of whom might later be excluded fromparticipating in the clinical trial for various reasons. Informationabout each person meeting the selection may additionally be provided,including information about other clinical trials that the personparticipated in and whether a placebo was administered.

[0034] The system may keep track of a plurality of clinical trials, andmaintain a list of person who were administered a placebo instead of thedrug being tested. In many cases, a person is disqualified from a trialif he or she participated in a trial for a similar drug; however, if itis determined that a placebo was administered, the system may beconfigured to not exclude the person. In other cases, the system wouldprovide information about the trial(s) that the person participated in.

[0035] A physician, such as physician 230, may be contacted if one oftheir patients meets the specified criteria for a clinical trial. Priorto releasing information to a drug company, it is generally necessary toobtain agreement of the patient's physician and an informed consent ofthe patient to participate in the trial. For example, the physician 230may recommend to a patient that a clinical trial being conducted by thedrug company 210 would be beneficial. The details of the trial may havebeen forwarded to the physician 230. Furthermore, physicians may benotified of their Institutional Review Board (IRB) statuses (e.g.,‘approved’, ‘pending’, or ‘not approved’. Expiration dates of theirstatus may be forwarded to approved physicians.

[0036] The clinical trials brokerage 250 can be notified that thepatient provided an intent to participate. When the necessary informedconsent information is obtained, the clinical trials brokerage 250 canprovide the identity of the patient (and other patient information) tothe drug company 210.

[0037] Preferably, the structured CPR 280 is populated with patientinformation using data mining techniques described in “Patient DataMining,” by Rao et al., Attorney Docket No. 2001P20906US01, copendingU.S. patent application Ser. No. 10/___,___, filed herewith, which isincorporated by reference herein in its entirety.

[0038] That disclosure teaches a data mining framework for mininghigh-quality structured clinical information. The data mining frameworkincludes a data miner that mines medical information from a computerizedpatient record based on domain-specific knowledge contained in aknowledge base. The data miner includes components for extractinginformation from the computerized patient record, combining allavailable evidence in a principled fashion over time, and drawinginferences from this combination process. The mined medical informationis stored in a structured computerized patient record.

[0039] To determine the specified criteria for the clinical study,multiple data sources typically need to be consulted. For example, todetermine whether the patient is diabetic, the system might have toexamine the following information:

[0040] (a) ICD-9 billing codes for secondary diagnoses associated withdiabetes;

[0041] (b) drugs administered to the patient that are associated withthe treatment of diabetes (e.g., insulin);

[0042] (c) patient's lab values that are diagnostic of diabetes (e.g.,two successive blood sugar readings over 250 mg/d);

[0043] (d) doctor mentions that the patient is a diabetic in the H&P(history & physical) or discharge note (free text); and

[0044] (e) patient procedures (e.g., foot exam) associated with being adiabetic.

[0045] As can be seen, there are multiple independent sources ofinformation, observations from which can support (with varying degreesof certainty) that the patient is diabetic (or more generally has somedisease/condition). Not all of them may be present, and in fact, in somecases, they may contradict each other. Probabilistic observations can bederived, with varying degrees of confidence. Then these observations(e.g., about the billing codes, the drugs, the lab tests, etc.) may beprobabilistically combined to come up with a final probability ofdiabetes.

[0046] Note that there may be information in the patient record thatcontradicts diabetes. For instance, the patient is has some stressfulepisode (e.g., an operation) and his blood sugar does not go up.

[0047] It should be appreciated that the selection of patients forclinical trials may be based on probabilistic information. Thus, a listof patients that meet the specified criteria may comprise a list ofpatients likely (e.g., according to a particular degree of confidence)to have met the criteria for the clinical trial.

[0048] Since it may be necessary to obtain additional information or toverify information about a participant, the clinical trials brokerage250 may output, or otherwise provide, questionnaires. Thesequestionnaires may be used to ascertain qualifications for the clinicaltrial. For example, the patient may be asked to provide a detailedfamily history of particular diseases.

[0049] In addition to providing a list of persons meeting the specifiedcriteria, the clinical trials brokerage 250 may also calculate variouscharges and fees. For example, participating physicians may need to becompensated. The drug company may be charged a fee for the list.Additionally, participants in the clinical trial may also becompensated.

[0050] In various embodiments of the present invention, lists of personswho are pre-qualified for certain types of clinical trials may begenerated. These lists of pre-qualified individuals may be madeavailable to drug companies or other entities interested in conducting aclinical trial.

[0051] Referring to FIG. 3, an alternate embodiment of the presentinvention is illustrated. In this embodiment, a clinical trialsbrokerage 350 is able to access a structured CPR 380 containing minedstructured patient information, and also a clinical trials database 390containing information about various clinical trials. The information inthe clinical trials database 390 may include information regarding thequalifications for clinical trials along with other informationregarding the trials. A patient, such as patient 335, may requestinformation about a particular clinical trial. The patient may eitherdirectly access the clinical trials brokerage 350 or go through aphysician, such as physician 330. The clinical trials brokerage 330 mayaccess the structured CPR 380 (populated with information in the samemanner as the CPR 280) to retrieve information about the patient, andattempt to match clinical trials of interest to the patient based on themedical history of the patient and available trials.

[0052] Referring to FIG. 4, a flow diagram outlining an exemplarytechnique for selecting a person for a clinical trial is illustrated.Beginning at step 401, a person is selected from among a set of personsmeeting specified criteria. This step may include receiving a requestfor a list of persons meeting specified criteria for a clinical trial,and retrieving a set of patient records from a data source to determinepersons meeting the specified criteria.

[0053] For example, a drug company might be interested in selectingblack males who are diabetic and have had a heart attack within the lastthree years. This might be used to test a new drug.

[0054] Using conventional approaches, satisfying the above-mentionedselection criteria could be difficult because computerized hospitaldatabases generally do not store such information. However, by employingthe data mining techniques described in “Patient Data Mining,” by Rao etal., Attorney Docket No. 2001P20906US01, copending U.S. patentapplication Ser. No. 10/___,___, filed herewith, a structured CPR can bepopulated with such patient information, thus allowing this selectioncriteria to be satisfied.

[0055] In step 402, the person's physician can be notified that theperson has been selected for the clinical trial. At this point, ahospital's Institutional Review Board (IRB) can also be notified. Thephysician can also be notified if IRB approval has already been grantedfor this trial at this site, or if he needs to wait for the IRB approvalfor this trial. Next, in step 403, a determination is made as to whetherthe physician will participate in the study. If it is determined thatthe physician will participate, control continues to step 404; otherwisecontrol terminates at step 408.

[0056] In step 404, the person is notified that he or she may qualifyfor the clinical trial. The patient can be directly contacted, or,indirectly contacted through a physician. At this point, the patient maybe given detailed information about the clinical trial. The patient maybe asked for additional information, such as through a questionnaire.The questionnaire may be used to determine qualification for the studyand/or as a way to obtain additional useful information.

[0057] Next, in step 405, a determination is made as to whether theperson indicated a desire to participate in the clinical trial. If theperson notified his or her physician of an intent to participate,control continues to step 406; otherwise control terminates at step 408.

[0058] In step 406, release information is obtained. At this point theperson may be provided with a consent form or be directed to completeone provided to him by his or her physician. Any information regardingparticipant compensation, including reimbursements, may also beprovided. Control continues to step 407.

[0059] In step 407, fees and charges may be determined. For instance,the entity requesting the list of patients may be charged an appropriatefee for the list of patients. Furthermore, the physician and trialparticipants may also be compensated for their participation in thestudy. Control continues to step 408 where the operation stops.

[0060] As shown in FIGS. 1-4, this invention is preferably implementedusing a general purpose computer system. However the systems and methodsof this invention can be implemented using any combination of one ormore programmed general purpose computers, programmed microprocessors ormicro-controllers and peripheral integrated circuit elements, ASIC orother integrated circuits, digital signal processors, hardwiredelectronic or logic circuits such as discrete element circuits,programmable logic devices such as a PLD, PLA, FPGA or PAL, or the like.In general, any device capable of implementing a finite state machinethat is in turn capable of implementing the flowchart shown in FIG. 4can be used to implement this system.

[0061] Although illustrative embodiments of the present invention havebeen described herein with reference to the accompanying drawings, it isto be understood that the invention is not limited to those preciseembodiments, and that various other changes and modifications may beaffected therein by one skilled in the art without departing from thescope or spirit of the invention.

What is claimed is:
 1. A system for selecting prospective participantsin a clinical trial, comprising: a data source containing patientinformation, at least some of the patient information obtained frommining unstructured patient records; and a clinical trials brokerage forretrieving a set of patient records from the data source and generatinga list of persons who meet specified criteria associated with theclinical trial.
 2. The system of claim 1, wherein the clinical trialsbrokerage is configured to obtain consent from one or more the personmeeting the specified criteria.
 3. The system of claim 1, wherein thelist of persons meeting the specified criteria is requested from anentity interested in performing the clinical trial.
 4. The system ofclaim 1, wherein the anonymity of the persons meeting the specifiedcriteria is preserved until consent is provided.
 5. The system of claim1, wherein the list of persons meeting specified criteria includespersons pre-qualified for the clinical trial.
 6. The system of claim 1,wherein the data source includes information collected from a pluralityof hospitals.
 7. The system of claim 1, wherein the specified criteriaincludes probability criteria.
 8. The system of claim 1, wherein theobtained patient records include probabilistic information.
 9. Thesystem of claim 1, wherein information needed to determine whether apatient qualifies in all respects is not included in the obtainedpatient records.
 10. The system of claim 1, wherein information abouteach person in the list is provided.
 11. The system of claim 10, whereinthe information includes information regarding previous clinical trialsthat the person participated in.
 12. A method for selecting prospectiveparticipants in a clinical trial, comprising the steps of: receiving arequest for a list of persons meeting specified criteria associated witha clinical trial; and retrieving a set of patient records from a datasource to determine persons meeting the specified criteria.
 13. Themethod of claim 12, further comprising the steps of: obtaining consentto participate in the clinical trial from one or more of the personsmeeting the specified criteria; and outputting a list of persons fromwhom consent was obtained.
 14. The method of claim 13, further includingthe step of forwarding the list of persons to an entity interested inperforming the clinical trial.
 15. The method of claim 13, wherein thestep of obtaining consent comprises the steps of: selecting physiciansassociated with the persons meeting the specified criteria; requestingapproval to participate from each of the selected physicians; andproviding consent information to persons meeting the specified criteriaif their physician provided approval to participate in the clinicaltrial.
 16. The method of claim 13, wherein obtaining consent includesnotifying physicians of their Institutional Review Board (IRB) statuses.17. The method of claim 16, wherein obtaining consent further includesforwarding to accepted status physicians expiration dates of their IRBapprovals.
 18. The method of claim 14, wherein the request for the listof persons is received from the entity interested in performing theclinical trial.
 19. The method of claim 12, wherein the anonymity of thepersons meeting the specified criteria is preserved until consent isprovided.
 20. The method of claim 12, further comprising the step ofproviding questionnaires.
 21. The method of claim 20, wherein thequestionnaires are used to ascertain qualification for the clinicaltrial.
 22. The method of claim 14, wherein the entity requesting thelist of patients is charged a fee for the list of patients.
 23. Themethod of claim 14, wherein persons participating in the clinical trialare compensated.
 24. The method of claim 15, wherein a participatingphysician is compensated.
 25. The method of claim 12, wherein the datasource is a data warehouse.
 26. The method of claim 25, wherein the datawarehouse is populated with structured patient information obtained frommining unstructured patient records.
 27. The method of claim 12, whereinthe request is received from a drug company.
 28. The method of claim 12,wherein the data source includes information collected from a pluralityof hospitals.
 29. The method of claim 12, wherein the specified criteriaincludes a probability value.
 30. The method of claim 29, wherein theprobability value includes a confidence interval.
 31. The method ofclaim 12, wherein the obtained patient records include probabilisticinformation.
 32. The method of claim 12, wherein information needed todetermine whether a patient qualifies in all respects is not included inthe obtained patient records.
 33. The method of claim 12, whereininformation about each person in the list is generated.
 34. The methodof claim 12, wherein the information includes information regardingprevious clinical trials that the person participated in.
 33. A programstorage device readable by a machine, tangibly embodying a program ofinstructions executable on the machine to perform method steps forselecting prospective participants in a clinical trial, the method stepscomprising: receiving a request for a list of persons meeting specifiedcriteria associated with a clinical trial; and retrieving a set ofpatient records from a data source to determine persons meeting thespecified criteria.
 34. A system for selecting prospective clinicaltrials for an individual patient, comprising: a clinical trialsdatabase; a data source containing patient information; and a clinicaltrials brokerage for generating a list of clinical trials for patientsmeeting specified criteria associated with the clinical trials.
 35. Thesystem of claim 34, wherein at least some of the information in the datasource containing patient information is obtained from miningunstructured patient records.